De Novo
DEN250046: Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
FDA De Novo · vitestro · decided Aug 19, 2026
Key facts
| De Novo number | DEN250046 |
|---|---|
| Device name | Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) |
| Applicant | vitestro |
| Product code | SIW |
| Date received | Sep 26, 2025 |
| Decision date | Aug 19, 2026 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
At a glance
- None Later 510(k)s citing this De Novo
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: